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Study of BEMA™ Buprenorphine in the Treatment of Dental Pain

This study has been completed.
Sponsor:
Information provided by:
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT00941304
First received: July 15, 2009
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
  Purpose

The purpose of this study is to assess the activity of BEMA™ Buprenorphine in the treatment of dental pain.


Condition Intervention Phase
Dental Pain
 Drug: oxycodone
Drug: BEMA™ Buprenorphine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Buprenorphine in the Treatment of Pain Associated With Third Molar Extraction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Sum of Pain Intensity Differences (SPID) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Opioid Drug: oxycodone
oral dose of standard opioid
Experimental: High Dose BEMA™ Buprenorphine Drug: BEMA™ Buprenorphine
Different oral transmucosal (inside of cheek) doses of experimental study drug
Experimental: Medium Dose BEMA™ Buprenorphine Drug: BEMA™ Buprenorphine
Different oral transmucosal (inside of cheek) doses of experimental study drug
Experimental: Low Dose BEMA™ Buprenorphine Drug: BEMA™ Buprenorphine
Different oral transmucosal (inside of cheek) doses of experimental study drug
Placebo Comparator: Placebo Drug: Placebo
Doses that look like the study drugs without active drug

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone
  • males or non-pregnant females, aged 18 to 45 years
  • good general health and capable of providing informed consent

Exclusion Criteria:

  • history of substance abuse or dependence
  • positive urine toxicology screen or alcohol breath test
  • history of hypersensitivity to or allergy to any study drug
  • donation of blood within prior 30 days
  • use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941304

Locations
United States, Texas
Austin, Texas, United States
San Marcos, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
BioDelivery Sciences International
Investigators
Study Director: David Blum, MD BioDelivery Sciences International
  More Information

No publications provided

Responsible Party: David Blum, MD, BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT00941304     History of Changes
Other Study ID Numbers: BUP-201
Study First Received: July 15, 2009
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Buprenorphine
Oxycodone
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013